Prospective randomised open-label comparison of danaparoid with dextran 70in the treatment of heparin-induced thrombocytopaenia with thrombosis - A clinical outcome study
Bh. Chong et al., Prospective randomised open-label comparison of danaparoid with dextran 70in the treatment of heparin-induced thrombocytopaenia with thrombosis - A clinical outcome study, THROMB HAEM, 86(5), 2001, pp. 1170-1175
Aim: To compare clinical outcomes in a randomised comparison of treatment w
ith danaparoid sodium (a heparinoid), or dextran 70, for heparin-induced th
rombocytopaenia (HIT) plus thrombosis. Methods: Forty-two patients with rec
ent thrombosis and a clinical diagnosis of probable HIT who presented at te
n Australian hospitals during a study period of six and one half years were
randomly assigned to open-label treatment with intravenous danaparoid or d
extran 70, each combined with oral warfarin. Thirty-four patients (83%) had
a positive platelet aggregation or C-14-serotonin release test for HIT ant
ibody. Twenty-five received danaparoid as a bolus injection of 2400 anti-Xa
units followed by 400 units per hour for 2 h, 300 units per hour for 2 It,
and then NO units per hour for five days, Seventeen received 1000 mL dextr
an 70 on day one and then 500 ml, on days 2-5. Patients were reviewed daily
for clinical evidence of thrombus progression or resolution, fresh thrombo
sis or embolism, bleeding or other complications. The primary trial endpoin
t was the proportion of thromboembolic events with complete clinical resolu
tion by the time of discharge from hospital. Results: With danaparoid, ther
e was complete clinical recovery from 56% of thromboembolic events compared
to 14% after dextran 70 (Odds Ratio 10.53, 95%, Confidence Interval 1.6-71
.4; p = 0.02). Clinical recovery with danaparoid was complete or partial in
86% of thromboembolic events compared with 53% after dextran 70 (Odds Rati
o 4.55, 95% Confidence Interval 1.2-16.7; p = 0.03). Overall clinical effec
tiveness of danaparoid was rated as high or moderate in 88% of patients com
pared with 47% for dextran 70 (p = 0.01). One patient given danaparoid C, d
ied of thrombosis compared with three patients given dextran 70. The platel
et count returned to normal after a mean of 6.7 days with danaparoid and 7.
3 days with dextran 70, There was no major bleeding with either treatment.
Conclusion: danaparoid plus warfarin treatment for HIT with thrombosis is e
ffective, safe, and superior to dextran 70 plus warfarin.